Transcutaneous Electroacupuncture for Gastroparesis (TEA)
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|ClinicalTrials.gov Identifier: NCT01469286|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : May 1, 2017
Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of patients with functional dyspepsia that affects about 10%-25% of the general population. Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of gastroparesis include nausea, vomiting, early satiety and abdominal bloating.
Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next to the stimulation electrodes and therefore the patient can resume normal daily activity while being treated by TEA. This is not only attractive but also more effective since TEA can be performed more often and for longer durations.
This exploratory project is designed to study the feasibility, efficacy and certain mechanisms of the proposed method of "wireless" TEA in patients with gastroparesis. Firstly the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly, the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis will be investigated in a double-blinded crossover design in patients with diabetic or idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of gastroparesis with TEA will be investigated.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Gastroparesis||Device: TEA Device: Sham-TEA||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Transcutaneous Electroacupuncture for Gastroparesis|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: TEA
Needleless electroacupuncture at ST36 and PC6
Electroacupuncture at ST36
Placebo Comparator: Sham-TEA
Needleless acupuncture at sham-points
Electroacupuncture at sham-points
- gastroparesis symptoms [ Time Frame: 4 weeks ]Gastroparetic symptom questionnaire will use the previously validated gastroparesis cardinal symptom index (GCSI), including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe).
- Gastric emptying [ Time Frame: 4 weeks ]Gastric emptying of a solid meal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469286
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39214|
|United States, Texas|
|Texas tech university health science center|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Jiande Chen, PhD||Transtimulation Research, Inc|